MedTrace Logo

A Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone Compared to OxyContin in Korean Cancer Patients

NCT01313780 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2017-12-22

Study results available
· View outcomes & findings →

Summary

Objectives:

To prove non-inferiority of Targin compared to Oxycontin in terms of change of pain intensity

1. Primary objective: Change of pain intensity (NRS 0-10) score (average pain over 24 hours obtained each evening) within 4 weeks
2. Secondary objectives: Bowel Habit (worsening/no change/improving), Total dose and frequency of rescue medication, Quality of Life (QOL; EORTC QLQ-C30), Duration to need of laxative use and Adverse events

Conditions

Interventions

DRUG

Oxycodone/Naloxone

Dose and administration : Upto 40mg B.I.D per daily.

DRUG

Oxycodone(single compound)

Dose and administration : Upto 40mg B.I.D per daily.

Sponsors & Collaborators

  • Mundipharma Korea Ltd

    lead INDUSTRY

Principal Investigators

  • Kim, M.D · Asan Medical Center

  • Ahn, M.D · Samsung Medical Center

  • Kim, M.D · National Cancer Center

  • Kim, M.D · SMG-SNU Boramae Medical Center

  • Lee, M.D · Shinchone Yonsei Severance Medical Center

  • Kang Jugnhoon · Kyungsang University Hospital

  • Lee Kyunghee, MD · Youngnam Univ. Hospital

  • Yoon Hwanjung, MD · Chungnam University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-10-31
Completion
2014-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01313780 on ClinicalTrials.gov